September 17, 2008 - See Notice (NOT-DK-08-022) Beginning with the December 8, 2008 submission date, all individual F30 and F32 fellowship applications assigned to NIDDK will be reviewed in study sections organized by the NIDDK Review Branch, rather than by the Center for Scientific Review (CSR).

Looking Ahead: As part of the Department of Health
and Human Services' implementation of e-Government, during FY 2006 the NIH
will gradually transition each research grant mechanism to electronic submission
through Grants.gov and the use of the SF 424 Research and Related (R&R)
forms. Therefore, once the transition is made for a specific grant mechanism,
investigators and institutions will be required to submit applications electronically
using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/.
NIH will announce each grant mechanism change in the NIH Guide to Grants and
Contracts (http://grants.nih.gov/grants/guide/index.html).
Specific funding opportunity announcements will also clearly indicate if Grants.gov
submission and the use of the SF424 (R&R) is required. Investigators should
consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm)
for the most current information when preparing a grant application.

The National Institutes of Health (NIH) awards individual
postdoctoral research training fellowships to promising applicants with
the potential to become productive, independent investigators in research
fields relevant to the missions of participating NIH Institutes and Centers.

The primary objective of this funding opportunity is
to help ensure that diverse pools of highly trained scientists will be available
in adequate numbers and in appropriate research areas to carry out the Nation’s
biomedical, behavioral and clinical research agendas.

The number of awards and the total amount of funding
that the participating NIH Institutes and Centers expect to award through
this announcement will depend on the scientific merit of applications received,
relevance to the program priorities of the participating NIH Institutes
and Centers, and the availability of funds.

Eligible organizations include for-profit and non-profit
organizations, public or private institutions such as universities, colleges,
hospitals and laboratories, units of State and local governments, eligible
agencies and labs of the Federal government including NIH intramural labs,
domestic or foreign institutions/organizations.

Applicant fellows must be citizens or non-citizen nationals
of the United States, or have been lawfully admitted to the United States
for permanent residence and have in their possession an Alien Registration
Receipt Card (I-151 or I-551), or other legal verification of such status
at the time of award. Non-citizen nationals are generally persons
born in outlying possessions of the United States, i.e. American Samoa and
Swains Island. Individuals on temporary or student visas are not eligible.
Individuals may apply for the F32 award in advance of admission to the United
States as a Permanent Resident recognizing that no award will be made until
legal verification of Permanent Resident status is provided.

An individual may not have two or more competing NIH
fellowship applications pending review concurrently. In addition, the NIH
Center for Scientific Review (CSR) will not accept for review any application
that is essentially the same as one already reviewed. This does not preclude
the submission of a substantial revision of an application already reviewed,
but such application must include an Introduction addressing the critique
of the previous application.

Applicants submitting revised applications must follow
the instructions for Revised Applications, PHS 416-1.
Up to two revised applications may be submitted.

It is important to note that the PHS 416-1
application form has been restructured and the instructions have been significantly
modified. See NOT-OD-07-002
released October 5, 2006

Telecommunications for the hearing impaired is available
at: TTY 301-451-5936.

The objective of the National Research Service Award (NRSA)
F32 program is to provide support to promising postdoctoral applicants who
have the potential to become productive and successful independent research
investigators in scientific health-related fields relevant to the missions
of the participating NIH Institutes and Centers (ICs).

The purpose of the National Research Service Award Act
(NRSA) is to help ensure that diverse pools of highly trained scientists will
be available in adequate numbers and in appropriate research areas to carry
out the Nation's biomedical, behavioral and clinical research agendas. The
National Institutes of Health (NIH) awards individual postdoctoral fellowships
(F32) to promising applicants who have the potential to become productive,
independent investigators in fields related to the mission of participating
NIH Institutes and Centers. The proposed postdoctoral training must be within
the broad scope of biomedical, behavioral, or clinical research or other specific
disciplines relevant to the research mission of the participating NIH Institutes
and Centers. The proposed training must offer an opportunity to enhance
the fellow's understanding of the health-related sciences and extend his/her
potential for a productive research career.

Postdoctoral applicants for this award must include a research training proposal
that documents the need for the research training and the expected value of
the proposed fellowship experience as it relates to the individual’s goals
for a career as an independent researcher.

The NRSA legislation requires that the Nation’s overall needs for biomedical
research personnel be taken into account by giving special consideration to
physicians and other health professionals who propose to become active biomedical
researchers and who agree to undertake a minimum of 2 years of biomedical,
behavioral or clinical research. NIH recognizes the critical importance of
training clinicians to become researchers and encourages them to apply.
For those who have a research doctoral health professional degree, the proposed
training may be used to satisfy a portion of the degree requirements for a
master's degree, a doctoral degree or any other advanced research degree program.
Individuals from diverse racial and ethnic groups and individuals with disabilities
and individuals from disadvantaged backgrounds are always encouraged to apply
for NIH support.

Research Training Program

Fellowship awardees are required to pursue their research training on a full-time
basis, normally defined as 40 hours per week, or as specified by the sponsoring
institution in accordance with its own policies. A Ruth L. Kirschstein-NRSA
fellowship (F32) may not be used to support studies leading to the MD., D.O.,
D.D.S., D.V.M., or other similar health-professional degrees. Neither
may these awards be used to support the clinical years of residency training.
Research clinicians must devote full-time to their proposed research training
and confine clinical duties to those activities that are part of the research
training program.

The sponsoring institution must have adequate faculty and facilities available
to provide a suitable environment for the high-quality research training experience.
The applicant’s research training should be guided and supervised by a committed
sponsor who is an active and established investigator in the area of the applicant’s
proposed research. The research training should occur in a research-intensive
environment that has appropriate human and technical resources and is demonstrably
committed to research training in the particular program proposed by the applicant.

Each NIH Institute and Center has a unique scientific purview
and different program goals and initiatives that evolve over time. Prior to
preparing an application, it is critical that all applicants consult the appropriate
Institute website (listed with each Institute's name at the beginning of this
announcement) for details of research areas supported by that Institute and
contact the appropriate Institute representative listed in the linked F32
Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-107_contacts.htm)
to obtain current information about Institute specific program priorities
and policies. This action is of utmost importance because applications with
marginal or no relevance to the participating Institutes will not be accepted
for review or possible funding.

This funding opportunity will use the Ruth L. Kirschstein
National Research Service Award (NRSA) for Individual Postdoctoral Fellows
(F32) award mechanism. As an applicant, the candidate and his/her sponsor
are jointly responsible for planning, directing, and executing the proposed
project. Information for participating Institute contacts and any IC
mission-specific initiatives for F32 programs may be found in (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-107_contacts.htm).

This mechanism is intended for candidates that will have
received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D.,
Dr. P.H., DNSc., N.D.(Doctor of Naturopathy), Pharm.D., D.S.W., Psy.D., or
equivalent doctoral degree from an accredited domestic or foreign institution
prior to activation of the award. Additional information and detailed requirements
for this NRSA award mechanism can be found at: http://grants.nih.gov/training/nrsa.htm
.

2. Funds Available

Although the financial plans of the NIH ICs provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the receipt of a sufficient number of meritorious applications,
the program priorities of the participating NIH ICs, and the availability
of funds.

Ruth L. Kirschstein-NRSA awards provide stipends to postdoctoral fellows
as a subsistence allowance to help defray living expenses during the research
training experience. The awards are not provided as a condition of employment
with either the Federal government or the sponsoring institution.
The stipend level for the first year of Ruth L. Kirschstein-NRSA support
is determined by the number of full years of relevant postdoctoral experience
at the time the award is issued (not at the time of activation, see below).
Fellows with less than one full year of postdoctoral experience at the time
of award will receive initial support at the zero level. Relevant experience
may include research (including research in industry), teaching, internship,
residency, clinical duties, or other time spent in full-time studies in a
health-related field beyond that of the qualifying doctoral degree. The current
stipend schedule is on the NIH website at http://grants.nih.gov/training/nrsa.htm
and the NIH Guide Notice released on January 9, 2006 located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html
. The awarding NIH IC will adjust awards on the anniversary date of the fellowship
award to ensure consistency with the stipend schedule in effect at that time.

The stipend for each subsequent year of Ruth L. Kirschstein-NRSA support
is the next level of experience using the stipend schedule in effect at that
time. Stipends will be adjusted on the anniversary date of the award
and will not be changed mid-year to accommodate an increase in the level of
experience. No departure from the published Ruth L. Kirschstein-NRSA stipend
schedule may be negotiated between the institution and the fellow.

For fellows sponsored by domestic non-federal institutions, the stipend will
be paid through the sponsoring institution. For fellows sponsored by Federal
or foreign institutions, the monthly stipend payment will be deposited in
the fellow's U.S. bank account or paid directly to the fellow by U. S. Department
of Treasury check.

Tuition and Fees

The NIH will offset the combined cost of tuition and fees at the rate in
place at the time of award. The rate currently in place, as indicated
in the NIH Guide announcement NOT-OD-06-093 released August 18, 2006, wiil
provide an amount per fellow equal to 60% of the level requested by the applicant
institution, up to $4,500 per year. If the program supports postdoctoral individuals
in a formal degree-granting training program, the amount provided per fellow
enrolled in a degree-granting program will be up to $16,000 per year Costs
associated with tuition and fees are allowable only if they are required for
specific courses in support of the research training experience supported
by the fellowship The current policy can be located at NOT-OD-06-093.

Institutional Allowance

The NIH provides an institutional allowance to help offset expenses such
as research supplies, equipment, health insurance (either self-only or family
as appropriate), and travel to scientific meetings. At the time of publication
of this funding opportunity announcement (and as indicated in NIH Guide Notice
NOT-OD-06-093),
fellows receive an institutional allowance of $7,850 per 12-month period to
nonfederal, nonprofit, or foreign sponsoring institutions. Support for health
insurance is allowable only if it is applied consistently for all individuals
in a similar research training status regardless of the source of support.
This allowance is intended to cover training related expenses for the individual
fellow, and is not available until the fellow officially activates the award.
If an individual fellow is enrolled or engaged in training for less than 6
months of the award year, only one-half of that year's allowance may be charged
to the grant. The Notice of Research Fellowship Award will be revised
and the balance must be returned to the NIH.

NIH will currently provide an institutional allowance of up to $6,750 for
fellows sponsored by Federal laboratories or for-profit institutions for expenses
associated with travel to scientific meetings, health insurance, and books.
For fellows at for-profit institutions, the $6,750 will be paid to the institution
for disbursement to the fellow. Funds for fellows at Federal laboratories
will be disbursed from the awarding IC.

The Institutional Allowance is adjusted from time-to-time. Prospective
applicants are advised to check for the current Institutional Allowance in
the most recent documentation related to Ruth L. Kirschstein-NRSA stipends
at http://grants.nih.gov/training/nrsa.htm.

Other Training Costs

Additional funds may be requested by the institution when
the training of a fellow involves exceptional circumstances. In all
cases, the additional funds requested must be reasonable in relationship to
the total dollars awarded under the fellowship and must be directly related
to the approved research training experience. Such additional funds
shall be provided only in exceptional circumstances that are fully justified
and explained by the sponsoring institution in the application.

Reasonable accommodations – As part of this award, additional
funds may be requested by the sponsoring institution to make changes
or adjustments in the academic or research environment that will make it
possible for an otherwise qualified individual with disabilities to perform
the work necessary to meet the requirements of the degree program in which
he/she is enrolled. Individuals with disabilities are defined as those
with a physical or mental impairment that substantially limits one or more
major life activities. The accommodations requested under this program
must be directly related to the work required to meet the requirements as
regards to both course work and laboratory experience, and must be appropriate
to the special needs of the applicant. Some types of accommodations that
might be provided under this award include, but are not limited to:
specialized equipment, assistive devices, and personnel such as readers,
interpreters, or assistants. This award is not meant to relieve the
sponsoring institution of its obligation to provide reasonable accommodations
as defined by the Americans with Disabilities Act. NIH will not provide
funds for infrastructure alterations such as lowering countertops, widening
doorways, etc.

Off-site research training – As part of this award,
additional funds may be requested by the sponsoring institution if the research
training of a fellow involves extraordinary costs for travel to field sites
remote from the sponsoring institution.

Foreign site research training – As part of this award,
applications that include training at a foreign site may include a single
economy or coach round-trip travel fare. No allowance is provided
for dependents. U.S. flag carriers must be used to the maximum extent
possible when commercial air transportation is available for travel between
the United States and a foreign country or between foreign countries.

Facilities and Administrative (F&A) Costs

Facilities and administrative costs are not allowed on individual fellowship
awards.

Supplementation of Stipends, Compensation, and Other Income

The sponsoring institution is allowed to provide funds to the fellow in addition
to the stipends paid by the NIH in accordance with its own formally established
policies governing stipend support. These policies must be consistently
applied to all individuals in a similar status, regardless of the source of
funds. Such additional amounts either may be in the form of augmented
stipends (supplementation) or in the form of compensation, such as salary
or tuition remission for services such as teaching or serving as a laboratory
assistant, provided the conditions described below are met. Under no
circumstances may the conditions of stipend supplementation or the services
provided for compensation interfere with, detract from, or prolong the fellow's
approved Ruth L. Kirschstein-NRSA training program.

Stipend Supplementation

Supplementation or additional support to offset the cost of living may be
provided by the sponsoring institution. Supplementation does not require additional
effort from the fellow. DHHS funds may not be used for supplementation
under any circumstances. Additionally, no funds from other Federal agencies
may be used for supplementation unless specifically authorized by the NIH
and the other Federal Agency.

Compensation

The sponsoring institution may provide additional funds to a fellow in the
form of compensation (as salary and/or tuition remission) for services such
as teaching or serving as a research assistant. A fellow may receive
compensation for services as a research assistant or in some other position
on a Federal research grant, including a DHHS research grant. However,
compensated services should occur on a limited, part-time basis apart from
the normal full time research training activities. In addition, compensation
may not be paid from a research grant supporting the fellow's research training
experience.

An individual may make use of Federal educational loan funds and assistance
under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds
are not considered supplementation or compensation. Postdoctoral fellows may
also be eligible to participate in the NIH Extramural Loan Repayment Program.
Information on this program is available at http://www.lrp.nih.gov/.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization
has any of the following characteristics:

For-profit organizations

Non-profit organizations

Public or private institutions, such as universities,
colleges, hospitals, and laboratories

Units of State and local governments

Eligible agencies and labs of the Federal government
including NIH intramural labs

Domestic Institutions

Foreign Institutions

The sponsoring institution must have staff and facilities
available on site to provide a suitable environment for performing high-quality
research training. An applicant must include in the application
the name of his/her sponsor who will supervise the training and research experience.

Applicants requesting fellowship support for foreign research
training must demonstrate in the application that the foreign institution
and sponsor offer unique opportunities and clear scientific advantages over
positions currently available in the United States. Only if there is a clear
scientific advantage will foreign training be supported.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research training is invited to work with
his/her sponsor and institution to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

Citizenship

By the time of award, the individual applying for the Kirschstein-NRSA
fellowship award must be a citizen or a noncitizen national of the United
States or have been lawfully admitted for permanent residence (i.e., possess
a currently valid Alien Registration Receipt Card I-551, or other legal verification
of such status). Non-citizen nationals are generally persons born in outlying
possessions of the United States (i.e., American Samoa and Swains Island).
Individuals on temporary or student visas are not eligible. Individuals may
apply for the F32 in advance of admission to the United States as a Permanent
Resident recognizing that no award will be made until legal verification of
Permanent Resident status is provided.

Degree Requirements

Before a Ruth L. Kirschstein-NRSA postdoctoral fellowship
award can be activated, the individual must have received a Ph.D., M.D.,
D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., DNSc.,
N.D.(Doctor of Naturopathy), Pharm.D., D.S.W., Psy.D., or equivalent
doctoral degree from an accredited domestic or foreign institution.
Certification by an authorized official of the degree-granting institution
that all degree requirements have been met is also acceptable.

An individual may not have two or more competing NIH fellowship
applications pending review concurrently. In addition, CSR will not accept
for review any application that is essentially the same as one already reviewed.

Duration of Support

Individuals may receive up to 3 years of aggregate Ruth L. Kirschstein-NRSA
support at the postdoctoral level, including any combination of support from
institutional training grants (T32) and individual fellowship awards (F32).
Applicants must consider any prior Ruth L. Kirschstein-NRSA postdoctoral research
training in determining the duration of fellowship support requested.
Training beyond the 3-year aggregate limit may be possible under certain exceptional
circumstances, but a waiver from the NIH awarding component is required. Individuals
seeking additional Ruth L. Kirschstein-NRSA support beyond the third year
are strongly advised to consult with relevant NIH staff before preparing a
justification. Any waiver will require a detailed justification of the
need for additional research training.

Sponsor

Before submitting a fellowship application, the applicant
must identify a sponsoring institution and an individual who will serve as
a sponsor (also referred to as mentor or supervisor) and will supervise the
training and research experience. The sponsor should be an active investigator
in the area of the proposed research who is committed to the research training
of the individual and will directly supervise the candidate's research. The
sponsor should document the availability of sufficient research support, facilities,
and didactic coursework if appropriate, for a high-quality research training
experience. Opportunities for the fellow to obtain additional guidance from
other subject matter experts during the research training experience are encouraged.
In some instances, it may be advisable for a co-sponsor to complement the
primary sponsor’s experience.

Sponsoring Institution

The sponsoring institution must have appropriate faculty
and facilities available on site to provide a suitable environment for high-quality
research training. In most cases, the F32 supports research training experiences
in new settings in order to maximize the acquisition of new skills and knowledge.
However, in unusual circumstances, applicants may propose postdoctoral training
experiences at their doctorate institution or at the institution where they
have been training for more than a year. In such cases, the applicant
must carefully document the opportunities for new research training experiences
specifically designed to broaden his/her scientific background.

Applicants requesting foreign training are required to
provide detailed justification for the foreign training, including the reasons
why the facilities, the sponsor, or other aspects of the proposed experience
are more appropriate than training in a domestic setting. The justification
is evaluated in terms of the scientific advantages of the foreign training
as compared to the training available domestically. Foreign training will
be considered for funding only when the scientific advantages are clear. Applicants
seeking training abroad are encouraged to contact the relevant participating
Institute or Center prior to preparing an application (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-107_contacts.htm).

The fellowship application instructions are available at
PHS 416-1 in an
interactive format. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Note that the PHS 416-1 has been restructured (Rev. 10/05) and the instructions
have been significantly modified. See the NIH Notice NOT-OD-07-002
released October 5, 2006.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the Ruth L. Kirschstein
National Research Service Award Individual Fellowship Application Form PHS
416-1. Applications must have a Dun and Bradstreet (D&B) Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained
by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B
number should be entered on line 13b of the face page of the PHS 416-1 form
(Rev, 10/05).

The title and number of this funding opportunity must be typed on line 3
of the face page of the application form. If the fellowship application is
submitted in response to a Program Announcement (PA) or Request for Application
(RFA) from a particular NIH IC, the applicant should identify the number of
the PA or RFA in Item 3.

Applications must include at least three sealed letters of reference using
the PHS 416-1 reference page. Applications without at least three letters
of reference may be delayed in review or returned to the applicant without
review. Information applicable to the required references is located
in the application instructions, Part 1 Preparing Your Application, E. Application
Section III.

If the applicant has been lawfully admitted to the United States for permanent
residence, the Permanent Resident of U.S. block should be checked on the Face
Page of the PHS 416-1 application. Applicants who have applied for and have
not yet been granted admission as a permanent resident should also insert
the word "pending." A notarized statement documenting legal admission
for permanent residence must be submitted prior to the issuance of an award.

3. Submission Dates and Times

Applications must be mailed on or before the receipt
date described below (Section
IV.3.A). Submission times N/A.

No application will be accepted without the applicant’s
signing the certification block on the face page of the application. Individuals
admitted to the United States as Permanent Residents must submit notarized
evidence of legal admission prior to the award.

3.C. Application Processing

Applications must be submitted on or before the application
receipt dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for completeness by CSR. Incomplete
applications will not be reviewed. At least three sealed letters of
reference must be submitted with the application.

The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application. The
NIH will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of a substantial revision
of an application already reviewed, but such application must include an Introduction
addressing the previous critique.

A Ruth L. Kirschstein-NRSA fellowship may not be held concurrently
with another federally sponsored fellowship or similar Federal award that
provides a stipend or otherwise duplicates provisions of this award.

Tax Liability

Internal Revenue Code Section 117 applies to the tax treatment
of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law
99-514, impacts on the tax liability of all individuals supported under the
NRSA program. Under that section, non-degree candidates are required to report
as gross income all stipends and any monies paid on their behalf for course
tuition and fees required for attendance. Degree candidates may exclude from
gross income (for tax purposes) any amount used for tuition and related expenses
such as fees, books, supplies, and equipment required for courses of instruction
at a qualified educational organization.

The IRS and Treasury Department released regulations in
January 2005 (Revenue Procedure 2005-11) clarifying the student exception
to the FICA (Social Security and Medicare) taxes for students employed by
a school, college, or university where the student is pursuing a course of
study. Our understanding is that these final regulations do not apply to or
impact Ruth L. Kirschstein-NRSA programs or awards. An NRSA stipend is provided
by the NIH as a subsistence allowance for Ruth L. Kirschstein-NRSA fellows
and trainees to help defray living expenses during the research training experience.
NRSA recipients are not considered employees of the Federal government or
the grantee institution for purposes of the award. We must note that the NIH
takes no position on the status of a particular taxpayer, nor does it have
the authority to dispense tax advice. The interpretation and implementation
of the tax laws are the domain of the IRS. Individuals should consult their
local IRS office about the applicability of the tax laws to their situation
and for information on their tax obligations.

Service Payback

As required by the NIH Revitalization Act of 1993, postdoctoral
fellows incur a service obligation of 1 month for each month of support during
the first 12 months of the Ruth L. Kirschstein-NRSA postdoctoral support.
The 13th and subsequent months of Ruth L. Kirschstein-NRSA support are acceptable
postdoctoral payback service. Thus, individuals who continue under the award
for 2 years will have paid off their first year obligation by the end of the
second year.

Applicants accepting an award for the first 12 months of a Ruth L. Kirschstein-NRSA
postdoctoral support must sign a payback agreement (PHS Form 6031) in
which they agree to engage in health-related research training, research,
and/or teaching for 12 months.

Those who do not pay back their obligation through continued Ruth L. Kirschstein-NRSA
supported training may satisfy their obligation by serving in a position in
which health- related research, research training, or teaching are the primary
activities. Such individuals must engage in research, research
training, or teaching at a rate of 20 or more hours per week averaged over
a full work-year. Payback service may be conducted in an academic, governmental,
commercial, or nonacademic environment, in the United States or in a foreign
country. Examples of acceptable payback service include research associateships/assistantships,
postdoctoral research fellowships, and college or high school science teaching
positions. Examples of unacceptable payback service include clinical practice
and administrative responsibilities not directly related to scientific research.

Payback service positions are arranged by the individual, not by the NIH.
The NIH will review and approve the activity at the end of the year in which
it occurs. Service to satisfy any outstanding obligation must be initiated
within 2 years after termination of Ruth L. Kirschstein-NRSA support, and
must be performed on a continuous basis. For individuals who fail to fulfill
their service obligation, the United States is entitled to recover the total
amount of Ruth L. Kirschstein-NRSA funds paid to the individual for the obligated
period plus interest at a rate determined by the Secretary of the U.S. Department
of Treasury. Financial payback must be completed within 3 years, beginning
on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS, may extend the period for
starting service, permit breaks in service, extend the period of repayment,
or otherwise waive the payback obligation when compliance would constitute
a substantial hardship against equity and good conscience.

Future Year Support: Funds for continuation
beyond the initial year are determined by the progress described in the continuation
application (PHS 416-9, rev. 10/05), the timely submission of all required
forms, and the availability of funds.

6. Other Submission Requirements

Applicants are advised to pay special attention to the
instructions in the PHS 416-1.
Please note several important changes and reminders on pages 1 and 2, and
the new biographical sketch format page. Applicants should follow the most
up-to-date PHS
416-1 application form and instructions at the time of application.

Sponsor

The applicant’s sponsor/mentor, who will directly supervise
the applicant’s research, should be an active investigator in the area of
the proposed research and meet the eligibility requirements in Section
III. The sponsor must describe in detail his/her commitment to and
proposed role in guiding the individual applicant during the research training
experience.

Training Plan

The sponsor must provide a tailored research training plan
for the applicant. The plan must list experiences that are specifically
planned for the fellow including classes, seminars, and opportunities for
interaction with other groups and scientists, and how these will assist the
applicant in achieving his/her research goals. Describe the research environment
and available research facilities and equipment. Indicate the relationship
of the proposed research training to the candidate's career goals. Describe
the skills and techniques that the candidate will learn as they relate to
the candidate's career goals.

The NIH strongly encourages NRSA postdoctoral fellows to
obtain instruction and training in grant writing in order to apply successfully
for future career development and research support. All postdoctoral
NRSA fellows should also be provided with instruction in laboratory and project
management.

Additionally, the quality of the facilities and related
resources (e.g., equipment, laboratory space, computer time, available research
support, etc.) must be described.

If the sponsoring institution is a foreign institution,
information must be provided describing how the institution and sponsor offer
unique opportunities for research training not currently available in the
United States.

Research Proposal

A description of the broad, long-term objectives and specific
aims, making reference to the health relatedness of the research proposal
must be included (page 2 of the application PHS 416-1, rev. 10/05).
The applicant must describe concisely the research design and methods for
achieving these goals, as well as the rationale and techniques planned to
pursue these goals.

Training Potential

The application must include statements addressing the
planned value of the proposed fellowship experience and research training
program, and how these relate to the applicant’s needs in preparation for
a career as an independent researcher.

Instruction in the Responsible Conduct of Research

Applications must include the sponsoring institution’s
plan to provide and the candidate's plans for obtaining instruction in the
responsible conduct of research, including the rationale, subject matter,
appropriateness, format, frequency and duration of instruction. The amount
and nature of faculty participation must be described. Although the NIH has
not established specific curriculum or format requirements for this training,
it is suggested that the following topics be covered: conflict of interest,
data sharing, responsible authorship, policies for handling misconduct, policies
regarding the use of human and animal subjects, and data management. Applications
without plans for training in responsible conduct of research will be considered
incomplete and may be returned without review. No award will be made if an
application lacks this component.

Human Subjects Research

If the proposed research involves human subjects, the applicant
must be responsive to the instructions in the current version of the PHS 416-1.
The adequacy of plans to include appropriate human subjects is included in
the fellowship evaluation (see Additional Review Criteria below). Note that
NIH defines children as individuals under 21 years of age. Consult the decision
tree for the exemptions that apply: http://grants.nih.gov/grants/peer/tree_children_hs.pdf.

Care and Use of Vertebrate Animals in Research

If vertebrate animals are to be used in the project, the
applicant must be responsive to the instructions in the current version of
the PHS 416-1. The adequacy of plans for the care and use of vertebrate animals
is assessed as part of the fellowship evaluation.

Biohazards

The investigator and the sponsoring institution are responsible
for protecting the environment and research personnel from hazardous conditions.
If materials or procedures are proposed that are potentially hazardous to
research personnel and/or the environment, please describe the procedures
to be taken in order to ensure adequate protection.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Sharing Model Organisms: If the development of model
organisms is anticipated, include a description of a specific plan for sharing
and distributing unique model organism research resources or state appropriate
reasons why such sharing is restricted or not possible. For many individual
fellowships it is anticipated that plans of this nature would have already
been reported to the NIH by your sponsor in his/her research application.
When this has occurred, indicate so in this section and include the appropriate
grant number. For additional information on this policy, see Sharing Model
Organisms Policy (PHS 416-1).
If model organisms are not part of the planned research training plan, omit
this section. This description is not included in the Research Training
Plan page limits.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be
considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will
be assigned to the participating ICs on the basis of established PHS referral
guidelines.

Applications receive two sequential levels of review. The
first level is an assessment of the merit of the research training by a Scientific
Review Group (SRG), composed primarily of non-government scientists selected
for their competence in research and research training in a scientific area
related to the application. After the SRG meeting, the Scientific Review Administrator
(SRA), a designated Federal official who coordinates the review of applications
for the SRG, prepares a written summary of the review of each application
and forwards it to the appropriate NIH Institute. Staff within the assigned
funding Institute or Center provides a second level of review.

As part of the initial merit review, applications:

May undergo a selection process in which only those
applications deemed to have the highest scientific merit , generally the
top half of application under review, will be discussed and assigned a priority
score

Will receive a written critique

Will receive a second level of review by appropriate
staff within the assigned NIH Institute or Center

The following will be considered in making funding decisions:

Overall scientific merit of the proposed project as
determined by peer review

The goal of the NIH NRSA F32 program is to provide support
to promising applicants with the potential to become productive and successful
independent research investigators in scientific health-related fields relevant
to the missions of the participating NIH Institutes and Centers. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research training
will have a substantial impact on the pursuit of this goal. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. The scientific review
group will use information in the letters of reference in consideration of
the review criteria. Note that an application does not need to be strong in
all categories to merit a favorable priority score. The final priority score
will reflect the overall evaluation of the entire application.

Review criteria:

1. Candidate

An assessment of the candidate's previous and current
academic and research performance

An assessment of the candidate’s potential to, and commitment
to, becoming an important contributor to biomedical, behavioral or clinical
science

2. Sponsor/Mentor and Training Environment

An assessment of the quality of the training environment
including the institutional commitment to research training , the quality
and availability of the facilities and related resources (e.g. equipment,
laboratory space, computer time, subject populations), and the availability
of research support

The qualifications of the sponsor as a mentor for the
proposed research training experience, as well as a researcher including
successful competition for research support

If applicable, the quality and appropriateness of unique
research training opportunities proposed at a foreign site that are not
available in the United States.

3. Research Training Proposal

The merit of the scientific proposal

The quality of the research training plan

Potential of the proposed research training to serve
as a sound foundation that will lead the candidate to a productive research
career

4. Training Potential

An assessment of the value of the proposed fellowship
experience as it relates to the candidate's needs in preparation for a career
as an independent researcher

2.A. Additional Review Criteria:

In addition to the above criteria, the following items
may be considered in the determination of scientific merit and the priority
score:

Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).

Inclusion of Women, Minorities and Children in Research:
The adequacy of plans to include subjects from both genders, all racial and
ethnic groups (and subgroups), and children as appropriate for the scientific
goals of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated. (See Inclusion Criteria in the sections
on Federal Citations, below).

Care and Use of Vertebrate Animals in Research:
If vertebrate animals are to be used in the project, the five items described
in I.C.7. of the PHS 416-1 fellowship application instructions (rev. 10/05)
will be assessed (see http://grants.nih.gov/grants/forms.htm).

Biohazards: If materials or procedures are
proposed that are potentially hazardous to research personnel and/or the environment,
determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Responsible Conduct of Research: Every NRSA
fellow must receive instruction in the responsible conduct of research (http://grants.nih.gov/grants/guide/notice-files/not92-236.html).
Applications must include the sponsoring institution’s plans to provide and
the candidate's plans for obtaining instruction in the responsible conduct
of research, including the rationale, subject matter, appropriateness, format,
frequency and duration of instruction. The amount and nature of faculty participation
must be described. The plan will be discussed after the overall determination
of merit, so that the review panel's evaluation of the plan will not be a
factor in the determination of the priority score. The plan will be judged
as acceptable or unacceptable. The acceptability of the plan will be described
in an administrative note of the summary statement. Regardless of the priority
score, an application with an unacceptable plan will not be funded until the
applicant provides a revised acceptable plan. Staff in the NIH awarding component
will judge the acceptability of the revised plan.

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

Sharing Model Organisms: For many individual fellowships it is anticipated
that plans for sharing model organisms would have already been reported to
the NIH by the sponsor in his/her research application. When this has occurred,
applicants will indicate so and include the appropriate grant number. However,
if the development of a new model organism is anticipated, applicants will
include a description of a specific plan for sharing and distributing unique
model organism research resources or state appropriate reasons why such sharing
is restricted or not possible.

The reviewers will assess the adequacy of plans for sharing model organisms,
and will describe their assessment of the sharing plan in an administrative
note, but will not include their assessment in the overall priority score.
The adequacy of the resources sharing plan will be considered by Program staff
of the funding IC when making recommendations about funding applications.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed,
the fellow applicant will be able to access his/her Summary Statement (written
critique) via the NIH eRA Commons. Refer to the NIH eRA Commons System (COM)
Users Guide for additional information regarding registration in the NIH eRA
Commons. Direct questions to the eRA Commons Help Desk at: http://ithelpdesk.nih.gov/eRA/
or by telephone: 301-402-7469 or 866-504-9552 (Toll Free).

If the application is under consideration for funding,
NIH will request “just-in-time” information from the applicant. A request
for just-in-time information should not be interpreted as indicating that
an award will be issued.

A formal notification in the form of a Notice of Research
Fellowship Award (NRFA) will be provided electronically to the designated
sponsoring institution business official listed on the face page of the application.
The NRFA may also be retrieved by the institution through its eRA Commons
account. The NRFA signed by the grants management officer is the authorizing
document indicating that an award has been made.

Selection of an application for award is not an authorization
to begin performance. An awardee has up to six months from the issue
date on the NRFA to activate the award.

Activation: No funds may be disbursed until the fellow has started
training under the award and an Activation Notice (PHS 416-5, Rev. 10/05)
and a Payback Agreement (PHS 6031, Rev. 10/05) has been submitted to the NIH.
A fellow has up to 6 months from the issue date on the award notice to activate
the award. Under unusual circumstances, an NIH Institute may grant an extension
of the activation period upon receipt of a specific request from the fellow.

Fellowships must be administered in accordance with the current NRSA section
of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm),
and any terms and conditions specified on the Notice of Research Fellowship
Award.

Leave Policies

In general, fellows may receive stipends during the normal periods of vacation
and holidays observed by individuals in comparable training positions at the
sponsoring institution. For the purpose of these awards, however, the period
between the spring and fall semesters is considered to be an active time of
research and research training and is not considered to be a vacation or holiday.
Fellows may receive stipends for up to 15 calendar days of sick leave per
year. Sick leave may be used for the medical conditions related to pregnancy
and childbirth. Fellows may also receive stipends for up to 30 calendar
days of parental leave per year for the adoption or the birth of a child when
those in comparable training positions at the grantee institution have access
to paid leave for this purpose and the use of parental leave is approved by
the program director.

A period of terminal leave is not permitted and payment may not be made from
fellowship funds for leave not taken. Fellows requiring periods of time away
from their research training experience longer than specified here must seek
approval from the NIH awarding component for an unpaid leave of absence.

Part-time training

While Ruth L. Kirschstein-NRSA awardees are required to pursue research training
full time, normally defined as 40 hours per week, or as specified by the sponsoring
institution in accordance with its own policies, under unusual and pressing
personal circumstances, a fellow may submit a written request to the awarding
component to permit less than full-time training. Such requests will
be considered on a case-by-case basis. They must be approved by the
awarding NIH Institute or Center in advance for each budget period.
The nature of the circumstances requiring the part-time training might include
medical conditions, disability, or pressing personal or family situations
such as child or elder care. Permission for part-time training will
not be approved to accommodate other sources of funding, job opportunities,
clinical practice, clinical training, or for other responsibilities associated
with the fellow's position at the institution. In each case, the fellow
must submit a written request countersigned by the sponsor and an appropriate
institutional business official that includes documentation supporting the
need for part-time training. The written request also must include an
estimate of the expected duration of the period of part-time training, an
assurance that the fellow intends to return to full-time training when that
becomes possible, and an assurance that the trainee intends to complete the
proposed research training program. In no case will it be permissible for
the fellow to be engaged in Ruth L. Kirschstein-NRSA supported research training
for less than 50 percent effort. Individuals who must reduce their commitment
to less than 50 percent effort must take a leave-of-absence from Ruth L. Kirschstein-NRSA
fellowship support. The fellowship notice of award will be reissued
and the stipend will be pro-rated during the period of any approved part-time
training. Part-time training may affect the rate of accrual or repayment of
the service obligation for postdoctoral fellows.

Certification Requirements

Individuals admitted to the United States as Permanent Residents must submit
notarized evidence of legal admission prior to the award. A Payback
Agreement Form (PHS 6031, Rev. 10/05) must accompany the Activation Notice
for any award that occurs during the individual's initial 12 months of Ruth
L. Kirschstein-NRSA postdoctoral support. When support ends, the fellow must
submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH. If the
fellow has a payback obligation, he or she must notify the NIH of any change
in address and submit Annual Payback Activities Certification Forms (PHS 6031-1,
Rev. 10/05) until the payback service obligation is satisfied. Forms
will be provided to awardees by the NIH awarding component. Forms may
also be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

Inventions

Fellowships made primarily for educational purposes are exempted from the
PHS invention requirements. F32 awards will not contain any provision
giving PHS rights to inventions made by the awardee.

Publication and Sharing of Research Results

NIH supports the practical application and sharing of outcomes of funded
research. Therefore, fellows should make the results and accomplishments
of their Ruth L. Kirschstein-NRSA fellowship activities available to the research
community and to the public at large. The grantee organization should
assist fellows in these activities, including the further development of discoveries
and inventions for furthering research and benefiting the public.

Fellows are encouraged to submit reports of their findings for publication
to the journals of their choice. Responsibility for direction of the
project should not be ascribed to the NIH. However, NIH support must
be acknowledged by a footnote in language similar to the following:
“This investigation was supported by National Institutes of Health under Ruth
L. Kirschstein National Research Service Award (number).” In addition,
federal funding must be acknowledged as provided in “Public
Policy Requirements and Objectives-Availability of Information-Acknowledgment
of Federal Funding.”

Copyrights

Except as otherwise provided in the terms and conditions of the award, the
recipient is free to arrange for copyright without approval when publications,
data, or other copyrightable works are developed in the course of work under
a PHS grant-supported project or activity. Any such copyrighted or copyrightable
works shall be subject to a royalty-free, nonexclusive, and irrevocable license
to the Government to reproduce, publish, or otherwise use them, and to authorize
others to do so for Federal Government purposes.

An awardee has up to six months from the issue date on
the Notice of Research Fellowship Award to activate the award using the Ruth
L. Kirschstein National Research Service Award Individual Fellowship Activation
Notice (PHS 416-5, Rev. 10/05) available at http://grants.nih.gov/grants/forms.htm.
Under unusual circumstances, an NIH Institute may grant an extension of the
activation period upon receipt of a specific request from the fellow. Such
a request must be countersigned by the Sponsor and an authorized institutional
official.

Payback Agreement

A Payback Agreement Form (PHS 6031, Rev. 10/05) must accompany
the Activation Notice for any award that occurs during the individual’s initial
12 months of Kirschstein-NRSA postdoctoral support.

Application for Continued Support

An awardee will be required to submit the form PHS 416-9,
Rev. 10/05, Continuation of an Individual National Research Service Award,
annually (http://grants.nih.gov/grants/funding/416-9/phs416-9.htm
as required in the NIH Grants Policy Statement. The report is due two months
before the beginning date of the next budget period and must include information
related to the current year's progress as well as the plans for the coming
year. Note that the instructions request that a listing of all courses and
publications completed during the past year be included in the application
for continued support.

Termination Notice

When support ends, the fellow must submit a Termination
Notice (PHS 416-7, Rev. 10/05) to the NIH within 30 days following termination.
If the fellow has a payback obligation, he or she must notify the NIH of any
change in address and submit Annual Payback Activities Certification Forms
(PHS 6031-1, Rev. 10/05) until the payback service obligation is satisfied.
Forms may be found at http://grants.nih.gov/grants/forms.htm.

Section VII. Agency Contacts

Each NIH Institute and Center has a unique scientific purview
and different program goals and initiatives that evolve over time. Prior to
preparing an application, it is critical that all applicants consult the appropriate
Institute website (listed with each Institute's name at the beginning of this
announcement) for details of research areas supported by that Institute.
Applicants should also contact the appropriate Institute representative to
obtain current information about specific program priorities and policies.
This action is of utmost importance because applications with marginal or
no relevance to the participating Institutes will not be accepted for review
or possible funding.

We encourage your inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
financial or grants management issues:

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving
human subjects must be evaluated with reference to the risks to the subjects,
the adequacy of protection against these risks, the potential benefits of
the research to the subjects and others, and the importance of the knowledge
gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring
should be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving interventions
that entail potential risks to the participants (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research
(see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects
or the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require
for all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must report
annual accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age
of 21) must be included in all clinical research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.

Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting
from 1) currently funded NIH research projects or 2) previously supported
NIH research projects if they are accepted for publication on or after May
2, 2005. The NIH Public Access Policy applies to all research grant and career
development award mechanisms, cooperative agreements, contracts, Institutional
and Individual Ruth L. Kirschstein National Research Service Awards, as well
as NIH intramural research studies. The Policy applies to peer-reviewed, original
research publications that have been supported in whole or in part with direct
costs from NIH, but it does not apply to book chapters, editorials, reviews,
or conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.

Access to Research Data through the Freedom of Information
Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised
to provide access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for
an indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this
in the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other
human subjects procedures given the potential for wider use of data collected
under this award.

Standards for Privacy of Individually Identifiable Health
Information:
The Department of Health and Human Services (DHHS) issued final modification
to the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act (HIPAA)
of 1996 that governs the protection of individually identifiable health information,
and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the
Privacy Rule reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the
HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly
accessible on-line journal articles. Unless otherwise specified in this
solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution reviewers
that their anonymity may be compromised when they directly access an Internet
site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or
more of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at
http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 487 of
the Public Health Service Act as amended (42 USC 288) and under Federal Regulations
42 CFR 66. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement.
The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide
a smoke-free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified
health professionals who have made a commitment to pursue a research career
involving clinical, pediatric, contraception, infertility, and health disparities
related areas. The LRP is an important component of NIH's efforts to recruit
and retain the next generation of researchers by providing the means for developing
a research career unfettered by the burden of student loan debt. Note that
an NIH grant is not required for eligibility and concurrent career award and
LRP applications are encouraged. The periods of career award and LRP award
may overlap providing the LRP recipient with the required commitment of time
and effort, as LRP awardees must commit at least 50% of their time (at least
20 hours per week based on a 40 hour week) for two years to the research.
For further information, please see: http://www.lrp.nih.gov/.